Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090895
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription AB No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/24/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090895s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-10 REMS - PROPOSAL - D-N-A

Label is not available on this site.

06/01/2017 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

OXYCODONE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202116 ALVOGEN
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202116 ALVOGEN
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 207418 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202116 ALVOGEN
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 207418 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English